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This phase I study proposes the use of systemic thiosulfate rescue to allow supradose intra-arterial cisplatin delivery to lung tumors. Eligible patients would be those with at least one lung lesion large enough of characterize angiographically. All patients will first undergo a CT arteriogram of the target tumor. Patients will then receive 2 treatments on 2 consecutive weeks. The primary endpoint will be toxicity, with secondary endpoint of response as measured on week 4. This pilot study will also determine how technically feasible it is to locate the blood supply to these tumors and deliver cisplatin.
If the first 6 patients do well, 6 additional patients will be accrued for a total of 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IA Cisplatin / IV Thiosulfate | Experimental | Single-arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin, Thiosulfate | Drug | Cisplatin (150 mg/m^2) is given as an intra-arterial bolus, once, on days 2 and 9 of treatment. Thiosulfate (9 g/m^2), is given concurrently with cisplatin as an intravenous push over 15-20 minutes followed by a 6-hour intravenous infusion of thiosulfate (12 g/m^2). |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events due to intra-arterial cisplatin administration | To characterize the toxicity of intra-arterial supradose cisplatin with thiosulfate rescue when delivered as two doses, one week apart, for patients with primary lung tumors and/or lung metastases. | One week after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic determination of the tumor response rate in patients with primary and metastatic lung tumors treated with intra-arterial supradose cisplatin. | 4 weeks after first dose of cisplatin | |
| Angiographic delineation of the vascular structure of primary lung tumors and lung metastases. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Daniels, M.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D013885 | Thiosulfates |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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|
| Once before treatment |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D013431 |
| Sulfates |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |